Associate Director, Regulatory Project Manager

The role

You will support the planning, coordination, and execution of complex global regulatory filings activities across the development portfolio. You will serve as a strategic partner to Regulatory Affairs leaders and cross-functional teams to ensure regulatory strategies are translated into actionable plans.

What you will do

• Lead regulatory project management activities for assigned development programs and major regulatory submission milestones.
• Partner with Global Regulatory Leads and cross-functional functional representatives to develop integrated submission and execution plans.
• Create, maintain, and communicate comprehensive project timelines, critical path, key milestones, risks, assumptions, and dependencies.
• Facilitate cross-functional team meetings, submission working groups, and external vendor/partner interactions.
• Monitor project progress and provide clear status reporting to regulatory leadership and key stakeholders.
• Coordinate submission readiness activities.
• Partner with functional representatives to manage resource needs, workload forecasting, and prioritization of critical activities.
• Drive issue resolution and escalation processes.
• Contribute to the development and continuous improvement of Regulatory Project Management processes, tools, templates, metrics, and governance practices.

Required qualifications

• Bachelor's degree in life sciences or related discipline
• 8-10 years of biotechnology, pharmaceutical, or related industry experience, including significant regulatory affairs, project management, or drug development experience.
• Demonstrated experience managing cross-functional projects supporting regulatory submissions and development programs.
• Knowledge of regulatory submission planning, eCTD structure, content development, and filing readiness activities.
• Ability to operate effectively in a fast-paced, highly collaborative environment with competing priorities.
• Proficiency with project management tools and systems used to support regulatory planning and execution e.g. Smartsheet, Office Timeline.

Nice to have

• advanced degree

About the company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. The company uses a Dynamo platform to integrate experimental and computational approaches to drug protein targets.